The US Food and Drug Administration (FDA) will meet tomorrow to discuss emergency use authorization of the Johnson & Johnson (J&J) COVID-19 vaccine candidate. If the vaccine is approved, Doctors Without Borders/Médecins Sans Frontières (MSF) calls on J&J to send its first shipments to COVAX for low- and middle-income countries, rather than high-income countries.
Last week, the UN Secretary General criticized the distribution of COVID-19 vaccines as “wildly uneven and unfair,” noting that 10 high-income countries had so far administered 75% of all vaccinations, while more than 130 countries have not received a single dose. In line with this unacceptable trend, nearly 1.5 billion doses of J&J’s vaccine are already tied up in advance purchase agreements, the majority of which (56%, or 801 million out of 1.439 billion doses) are committed to high-income countries.*
J&J has submitted its vaccine to the World Health Organization (WHO) for emergency use listing, which is required to supply the COVAX Facility, a global COVID-19 vaccine purchasing mechanism aimed to improve equity of vaccination. The corporation has pledged to supply up to 500 million doses to COVAX over the next few years (only 100 million doses in 2021), however the agreement remains a non-binding memorandum of understanding.
The vaccine could be an important tool in the world’s response to this pandemic – particularly in low-resource settings where MSF works – since unlike the other COVID-19 vaccines being used today, it could require only one dose and could be stored at normal refrigerator temperatures. Preliminary data from a phase 3 trial testing the vaccine also suggest that the vaccine is effective against the 501Y.V2 COVID-19 variant, first identified in South Africa. South Africa is considered to be the first country rolling out the one-shot J&J vaccine. The county is currently vaccinating frontline healthcare workers with the first batches of up to 500,000 free doses that J&J had set aside for global clinical trial stocks.
J&J received US$1.5 billion from the US government for research and development of its COVID-19 vaccine, and the UK government is co-funding a global clinical trial testing a two-dose regimen of the vaccine. From early on in the pandemic, and in light of this significant public investment, MSF has called for any potential future COVID-19 vaccines to be priced at cost. J&J has committed to a $10 ‘non-profit’ price for emergency use during the pandemic. In a US Senate hearing last year, J&J committed to having its prices audited externally, and MSF urges the corporation to open its books.
Quote from Dana Gill, US Policy Advisor, MSF Access Campaign:
“We welcome the news that another possible COVID-19 vaccine approval is imminent, but for it to be really meaningful in the world’s response to the pandemic, it’s critical that the vaccine is distributed equitably across the world, not just supplied to the highest bidders first. J&J should supply low- and middle-income countries and immediately fulfil its pledge to the COVAX Facility. It is simply unfair that most of J&J’s vaccine doses are pledged to wealthy countries with already significant stockpiles of the other approved vaccines, where immunizations have been underway for nearly three months, while low- and middle-income countries where barely any vaccination has taken place are left at the back of the queue. It’s likely that by the time the vaccine is approved by WHO for use for the COVAX Facility, wealthier countries will have vaccinated most of their priority groups, while healthcare workers in low- and middle-income countries will remain largely unvaccinated.
MSF witnessed the horrible impact the second wave of COVID-19 infections had in southern Africa, where a surge in new cases aggravated by the appearance of a more infectious variant overwhelmed already limited healthcare resources. The J&J vaccine has been shown to have efficacy against the 501Y.V2 variant, but MSF is worried that if J&J continues with business-as-usual tactics, countries most affected by this variant will once again be left waiting at the back of the queue. For example, South Africa has the highest prevalence of this variant in the world and has been a critical partner in J&J’s clinical trials, yet the country is due to receive a mere 9 million of the 300 million doses that will be filled in vials and packaged by a local manufacturer. J&J should right away ensure that South Africa receives, at minimum, enough doses to vaccinate its healthcare workers and high-risk groups, as well as prioritise shipments to other low- and middle-income countries.”
*According to data from AirFinity (January 27, 2021)